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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03900104
Other study ID # CEIN
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2019
Est. completion date January 15, 2020

Study information

Verified date February 2020
Source Kocaeli University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators think that trans-cervical endometrial tracer injection will cause more paraaortic sentinel lymph node detection. Also, this application is easy, cost-effective and safer than hysteroscopic method. Transtubal tumor spearing will not occur with this method.


Description:

Endometrial tracer injection will be performed by cervical or transcervical endometrial methods. Pelvic and para-aortic sentinel lymph node detection capacity will be assessed in this study.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date January 15, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Endometrial Cancer Patients

- Suitable patients for surgical staging

Exclusion Criteria:

- Patients who cannot undergo cervical or transcervical endometrial injection

- Pathology did not confirm endometrial cancer

- Sarcoma of the uterine corpus

- If a 90-day follow-up was not feasible

Study Design


Intervention

Procedure:
Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particles
Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particles, in 5 mL saline, 2 hours before surgery. Injection performed with a trans-cervical catheter
Cervical injection of technetium 99 m-labeled human albumin colloid particles
Cervical injection of technetium 99 m-labeled human albumin colloid particles, in 5 mL saline, 2 hours before surgery.

Locations

Country Name City State
Turkey Kocaeli University Kocaeli

Sponsors (1)

Lead Sponsor Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Niikura H, Kaiho-Sakuma M, Tokunaga H, Toyoshima M, Utsunomiya H, Nagase S, Takano T, Watanabe M, Ito K, Yaegashi N. Tracer injection sites and combinations for sentinel lymph node detection in patients with endometrial cancer. Gynecol Oncol. 2013 Nov;131(2):299-303. doi: 10.1016/j.ygyno.2013.08.018. Epub 2013 Aug 27. — View Citation

Solima E, Martinelli F, Ditto A, Maccauro M, Carcangiu M, Mariani L, Kusamura S, Fontanelli R, Grijuela B, Raspagliesi F. Diagnostic accuracy of sentinel node in endometrial cancer by using hysteroscopic injection of radiolabeled tracer. Gynecol Oncol. 2012 Sep;126(3):419-23. doi: 10.1016/j.ygyno.2012.05.025. Epub 2012 May 30. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Detected pelvic and paraaortic sentinel lymph node numbers Detected pelvic and paraaortic sentinel lymph node numbers in pathological examination (Ultrastaging) Postoperative 30 days
Secondary Numbers adverse events Number of adverse events associated with the surgery Postoperative 90 days
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